Cardiac ComplicationCardiacNCT06583200
Fluid Responsiveness in Post Cardiac Surgery Patients
A study testing End Expiratory Occlusion Test and Passive Leg Raising Test in people with Cardiac Complication, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to compare end expiratory occlusion test to passive leg raising test for prediction of fluid responsiveness in post cardiac surgery mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Complication
- What is being tested?
- End Expiratory Occlusion Test and Passive Leg Raising Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age group: 21-60years old
- Sex: eligible both sexes
- Post cardiac surgery
- Sedated intubated mechanically ventilated patients (Controlled ventilation with no respiratory effort)
Who cannot join
- Patients refusal
- Pregnancy or any medical condition that may affect the intra abdominal pressure.
- Lower limb deep venous thrombosis Open chest conditions impaired left-ventricular ejection fraction (<45%), arrhythmias, inter-ventricular shunt, severe peripheral arterial occlusive disease and the need for intra-aortic balloon counter pulsation
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine Ain Shams University
Cairo, Cairo Governorate, 000
About this study
Official title: End Expiratory Occlusion Test for Evaluation of Fluid Responsiveness in Comparison to Passive Leg Raising Test in Mechanically Ventilated Post Cardiac Surgery Patients
The aim of the study is to compare end expiratory occlusion test to passive leg raising test for prediction of fluid responsiveness in post cardiac surgery mechanically ventilated patients.
Read the detailed description
Circulatory hypervolemia and hypovolemia are both associated with worse outcomes.Intravenous fluids are similar to drugs, with serious adverse effects and changeful efficacy. Fluids should be administered only if indicated. Passive leg raising test transiently increase venous return which can be used to evaluate fluid responsiveness.There is growing evidence that the End expiratory occlusion (EEO) test reliably detects fluid responsiveness. In patients under mechanical ventilation, the inspiration increases intra-thoracic pressure and decreases venous return. The expiratory hold augments the cardiac preload which, in case of preload responsiveness, leads to a significant increase of cardiac output (CO).EEO prevents any variation in intra-thoracic pressure leading to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. There're no studies comparing EEO with passive leg raising test in cardiac surgery patients. So, this is the target of the study.
- Conditions
- Cardiac Complication
- Being tested
- End Expiratory Occlusion Test, Passive Leg Raising Test
- Keywords
- Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End Expiratory Occlusion TestDiagnostic test
All studied mechanically ventilated patients under post operative sedation. EEO test will be applied to predict probable responder and probable non-responder according to pulse pressure variation in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of 5% or more
Passive Leg Raising TestDiagnostic test
All studied mechanically ventilated patients under post operative sedation.Passive leg raising test will be applied to predict probable responder and probable non-responder according to the PPV in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of at least 10%
| Study group | Role | What they receive |
|---|---|---|
| End Expiratory Occlusion Test | Other | Pulse pressure variation before and after end expiratory occlusion test Receives: Diagnostic Test: End Expiratory Occlusion Test; Diagnostic Test: Passive Leg Raising Test |
| Passive leg raising test | Other | Pulse pressure variation before and after passive leg raising test Receives: Diagnostic Test: End Expiratory Occlusion Test; Diagnostic Test: Passive Leg Raising Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of EEO and passive leg raising
Predictive value of EEO and passive leg raising to fluid responsiveness in post cardiac surgery mechanically ventilated patients Pulse pressure variation before and after passive leg raising test
Measured: One year
Secondary outcomes (2)
Arterial blood pressure
Effect of EEO and passive leg raising to fluid responsiveness on arterial blood pressure in post cardiac surgery mechanically ventilated patients
Measured: One year
Heart rate
Effect of EEO and passive leg raising to fluid responsiveness on heart rate in post cardiac surgery mechanically ventilated patients
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Jan 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion12 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwa Khairy, Professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583200
- Sponsor's protocol ID
- FAMSU MD 220/2022
- Acronym
- Cardiac
- Status last verified
- Apr 2024
- First submitted
- 3 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End Expiratory Occlusion Test for Evaluation of Fluid Responsiveness in Comparison to Passive Leg Raising Test in Mechanically Ventilated Post Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT06583200
- Acronym / sponsor ID
- Cardiac / FAMSU MD 220/2022
- Conditions
- Cardiac Complication
- Keywords
- Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 12 Sep 2024 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare end expiratory occlusion test to passive leg raising test for prediction of fluid responsiveness in post cardiac surgery mechanically ventilated patients.
Detailed description
Circulatory hypervolemia and hypovolemia are both associated with worse outcomes.Intravenous fluids are similar to drugs, with serious adverse effects and changeful efficacy. Fluids should be administered only if indicated. Passive leg raising test transiently increase venous return which can be used to evaluate fluid responsiveness.There is growing evidence that the End expiratory occlusion (EEO) test reliably detects fluid responsiveness. In patients under mechanical ventilation, the inspiration increases intra-thoracic pressure and decreases venous return. The expiratory hold augments the cardiac preload which, in case of preload responsiveness, leads to a significant increase of cardiac output (CO).EEO prevents any variation in intra-thoracic pressure leading to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. There're no studies comparing EEO with passive leg raising test in cardiac surgery patients. So, this is the target of the study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End Expiratory Occlusion Test | Other | Diagnostic Test: End Expiratory Occlusion Test, Diagnostic Test: Passive Leg Raising TestPulse pressure variation before and after end expiratory occlusion test |
| Passive leg raising test | Other | Diagnostic Test: End Expiratory Occlusion Test, Diagnostic Test: Passive Leg Raising TestPulse pressure variation before and after passive leg raising test |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age group: 21-60years old
- Sex: eligible both sexes
- Post cardiac surgery
- Sedated intubated mechanically ventilated patients (Controlled ventilation with no respiratory effort)
Key exclusion criteria (3 listed)
- Patients refusal
- Pregnancy or any medical condition that may affect the intra abdominal pressure.
- Lower limb deep venous thrombosis Open chest conditions impaired left-ventricular ejection fraction (<45%), arrhythmias, inter-ventricular shunt, severe peripheral arterial occlusive disease and the need for intra-aortic balloon counter pulsation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| End Expiratory Occlusion TestAll studied mechanically ventilated patients under post operative sedation. EEO test will be applied to predict probable responder and probable non-responder according to pulse pressure variation in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of 5% or more | Diagnostic test | End Expiratory Occlusion Test, Passive leg raising test |
| Passive Leg Raising TestAll studied mechanically ventilated patients under post operative sedation.Passive leg raising test will be applied to predict probable responder and probable non-responder according to the PPV in accordance to previous study where the response to volume expansion was defined as an increase in pulse pressure of at least 10% | Diagnostic test | End Expiratory Occlusion Test, Passive leg raising test |
Primary outcome
Predictive value of EEO and passive leg raising
Time frame: One year
Predictive value of EEO and passive leg raising to fluid responsiveness in post cardiac surgery mechanically ventilated patients Pulse pressure variation before and after passive leg raising test
2 secondary outcomes
Arterial blood pressure
Time frame: One year
Heart rate
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Khairy, Professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End Expiratory Occlusion Test and Passive Leg Raising Test in people with Cardiac Complication, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of EEO and passive leg raising (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.